Postprandial Responses to Hydroxytyrosol-enriched Bread

Postprandial Responses Clinical Trial

Official title:

Postprandial Responses of Healthy Subjects to Wheat Bread Enriched With Encapsulated Hydroxytyrosol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04725955
• Other study ID #: Harokopio_Hydroxytyrosol
• Status: Completed
• Phase: N/A
• Start date: January 31, 2021
• Est. completion date: November 15, 2021

Study information

• Verified date: November 2021
• Source: Harokopio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The amelioration of postprandial glucose and insulin responses to bread is of great importance since it may have significant beneficial effects on health. A number of studies have shown that hydroxytyrosol may have positive metabolic effects. However, this compound presents high hydrophilicity which constitutes the major barrier to its potential application in foods. Microencapsulation arises as a technological strategy to protect it and increase its stability. Alpha-cyclodextrin besides being a great carrier molecule, seems to also be beneficial to postprandial glucose levels. Enrichment of bread with encapsulated hydroxytyrosol could examine potential postprandial benefits.

Ten healthy normoglycemic subjects will participate in the study and will be provided with either a solution of glucose (reference food) or white wheat bread or wheat bread enriched with a-cyclodextrin or wheat bread enriched with hydroxytyrosol encapsulated in a-cyclodextrin, with 1-week intervals in amounts that yielded 50 g of available carbohydrates. Venous blood samples will be collected before consumption and at 30, 45, 60, 90, 120 and 180 min postprandially. Postprandial glucose, insulin and appetite-related hormone responses as well as glycemic index (GI) and subjective appetite ratings will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 15, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Normal body mass index

• Stable body weight for at least 3 months before enrollment

• Normal exercise, eating and drinking habits

Exclusion Criteria:

• Pregnancy and lactation

• Chronic medical illness (diabetes mellitus, cardiovascular disease, chronic liver, kidney, polycystic ovary syndrome or untreated thyroid disease)

• Use of nutritional supplements

• History of drug and/or alcohol abuse

• Psychiatric disease

Related Conditions & MeSH terms

• Postprandial Responses

Intervention

Other:
• Enriched wheat bread
Either 50g of glucose dissolved in 250mL water or white wheat bread or wheat bread enriched with 5mg a-cyclodextrin or wheat bread enriched with a 5mg mixture of a-cyclodextrin and encapsulated hydroxytyrosol (per 50g of available carbohydrates).

Locations

Country	Name	City	State
Greece	Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens	Athens	Attiki

Sponsors (2)

Lead Sponsor	Collaborator
Harokopio University	National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycaemic Index	Glycaemic Index of the enriched breads	Change between preprandial glucose measurements until 120 minutes postprandially
Secondary	Insulin Response	Insulin Responses of the volunteers to the enriched breads (by a sandwich ELISA method, using a commercially available human insulin kit)	Change between preprandial insulin measurements until 180 minutes postprandially
Secondary	Appetite ratings	Appetite ratings after the consumption of the enriched breads (evaluation of subjective appetite ratings, use of visual analogue scales)	Change between preprandial subjective appetite measurements until 180 minutes postprandially